Kim Sablich: Yes. Really happy with the 11% year-over-year growth we saw in the third quarter. And we’ll say that the increased demand this quarter is partially attributed to the temporary platinum chemotherapy shortage that unfortunately the U.S. is going through, which did lead Zepzelca to be used in some patients. Oncologists may have historically rechallenged with another round of platinum therapy after their first-line platinum treatment, and we’ve really been emphasizing for some time that this is where the results with Zepzelca are most impressive, but it’s been difficult getting some of the customers to make this switch. We did roll out this past few months, some new data that we haven’t shared with customers before in this platinum-sensitive patient population to help them feel more comfortable using it.
We shared the secondary endpoint results we had around overall survival and progression-free survival. So I think the combination of that data with the shortage of chemotherapy, did lead many customers to give it a try there. And largely, we think that they’re seeing positive results that even when the platinum supply shortage continues to improve, which we hope it does, we do anticipate that some of these health care providers — some of them may revert back to their previous practice of reals with platinum, others may now reach for Zepzelca more often. In addition, we saw many HCPs getting experience with this product in the community and outpatient setting. And we’re really impressed with the ease of administration as well as the clinical profile.
Remember Zepzelca doesn’t require any inpatient monitoring. So again, that business that we think may continue to be a bit sticky after the shortage. So overall, Zepzelca is well established as the treatment of choice in second-line small cell lung cancer, and we think we’ve gotten some nice momentum here from this market event, but we really do see most of the opportunity for future growth in this brand coming from the first-line setting, and we’ve got a Phase III trial going on there now.
Operator: Your next question from the line of Balaji Prasad from Barclays Capital.
Balaji Prasad: Looking at [indiscernible] on Epidiolex, could we like the well-defined patient populations in narcolepsy or IH or oncology, this is one where the market sizing still seems incomplete. So can you discuss the opportunity in the adult setting, as you spoke about this afternoon, the additional ex-U.S. launches? And what would this translate to in terms of an expansion of market size. Maybe an extended — a related question, as you continuously call out that it’s well on its way to $1 billion. What can we expect beyond this in terms of longer-term growth trajectory? Is it going to be mid-single digits or high single digits? How can we think about it?
Renee Gala: Thanks for the question, Balaji. I’ll jump in on that one. So I’ll just note as you know we don’t provide product-specific guidance, but I will comment on the broader opportunity and that I’ll turn it to Kim to talk about some of the very specific dynamics that we’re seeing in the U.S. So when you think about the growth that we saw in the current quarter, we had 9% year-over-year. But importantly, we had 14%, if you look at the first 9 months of this year, compared to the prior period. So we are confident we’re on track for blockbuster status and in line with our Vision 2025 expectations. And I think — when you think about Epidiolex, there are 3 areas to keep in mind in terms of important growth drivers. One, this is a global product.
As you’ve noted, that means global opportunities for expansion and growth. We’re now approved and reimbursed in 24 different countries. We have the pivotal study underway in Japan, which we expect to read out at the end of next year. And then we have strong underlying demand growth also in the U.S., which Kim will comment on in a moment. We also view Epidiolex continue to view this as very much a long-lived durable asset. We have a robust portfolio of Orange book-listed patents, the majority of which go out to 2035, but also 2039. We do see this as something that is very much a long-term revenue drive for the company. And then third, perhaps most importantly, it’s a highly differentiated treatment. Epidiolex is very well characterized and tolerated, which, of course, lends itself well to polypharmacy, which is the norm in this area, we’ve generated significant data around its use, which HCPs are finding helpful.
And this really underpins our investment in data such as the EpiCom study that I mentioned before. And all 3 of these main factors give us collective confidence in that long-term potential. Specific to some of ex-U.S. dynamics, we had a number of launches in different countries and across different indications across ’23, and we expect that to continue in 2024. So maybe I’ll turn it to Kim to comment on adults long-term care segment and other demand — sorry, drivers of demand.
Kim Sablich: Sure. Thanks, Renee. So yes, I think we’ve talked about for the last year or so, we’ve really been putting I think, increased focus on the adult segment there and particularly as it pertains into U.S. to the long-term care setting where many of the adults with these conditions revived. And we’re seeing really nice growth there in that population disproportionate to what we’re seeing in the brand overall. So that is a nice growth driver. But across both the pediatric and adult market, there are, I’d say, 3 other things that are really driving the growth, and I think speak well for the future. Renee mentioned the data. We’ve talked quite a bit with you about the data. We are sharing the data regarding combination with clobazam and the beyond seizure benefits of Epidiolex particularly as it relates to behavioral improvements and cognition improvements specifically because we’re trying to expand the definition of efficacy and really differentiate the brand from existing products today.
And I’d say both of these pieces of data really are eye opening and do a great job of that in the marketplace, particularly that beyond seizure data in the LGS and Dravet space. The third one is that we have done a really nice job, I think, over the last couple of years of expanding, I would say, or improving the quality of access to Epidiolex. Pretty much since launch, we had a very high percentage of commercial lives that have coverage as well as Medicaid lives that have coverage for Epidiolex. But what we’ve really seen in the last couple of years and this year in particular, is that the quality of that coverage is improving in terms of the utilization management criteria becoming less burdensome. The utilization management criteria being broader in terms of providing easier access to Epidiolex for a broad range of patients with refractory conditions.
And ultimately, we are hearing from our customers’ feedback that they are finding it easier to get their patients Epidiolex, which, of course, only reinforces their confidence in prescribing it. And then lastly, persistency has been really a hallmark of this brand since it was launched similar to activate once patients get through the early titration period, they tend to stay on Epidiolex for a long time. But despite this, we still have seen room for opportunity to invest in improving that persistency, both at the beginning of the treatment and when patients have been on it for some time, and we’re seeing nice improvements there, particularly if we can get ACPs to support patients and get them up through that titration period. Overall, we see them stay on the drug for a pretty long time.
So lots of things there to point to as current and, I think, future growth drivers in the U.S.
Operator: Your next question comes from the line of Akash Tewari from Jefferies.
Amy Li: This is Amy on for Akash. So we have one quick question on orexin. So you are guiding to data for JZP-441 in healthy volunteers by year-end. I guess, what level of MWT do you need to see to move this program forward? Also, what makes you feel comfortable about the liver tox profile?
Robert Iannone: Sure. Should I take that one, Bruce?
Bruce Cozadd: Yes, please.
Robert Iannone: Yes. So we have certainly some benchmarks with other orexin agonists that are in the clinic. So in terms of what we’d be looking for, in the healthy volunteer MWT study is comparable efficacy. And I think that model translates pretty well into patients. And so we have the benefit of benchmarking across a range of doses that we’re evaluating versus other compounds, not only in the orexin class, but also other wake-promoting agents. So I think we’ll have a good sense of when we hit a level of efficacy a little confident moving forward with. And then — sorry, the second part of the question was?
Amy Li: Liver tox profile, how — what makes you feel — yes.
